MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE 5MM SHEAR; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HARXX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Sepsis (2067); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: publication year of 2014.Medical device: batch # unk.This report is related to a journal article; therefore, no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot/batch number has not been provided.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.In regard to the harmonic device; can you please provide the specific number of patients who had post-operative events of symptomatic fluid collection? can you please provide the specific number of patients who had post-operative events of bile leak? can you please provide the specific number of patients who had post-operative events of bleeding? can you please provide the specific number of patients who had post-operative events of liver insufficiency? can you please provide the specific number of patients who had post-operative events of sepsis? can you please provide the specific number of patients who had post-operative events of stenosis of the bile duct? was the bleeding an excessive amount? how was the bleeding controlled? what was done to treat the bile leak? what was done to treat the symptomatic fluid collection? what was done to treat the liver insuffiency? what was done to treat the sepsis? what was done to treat the stenosis of bile duct? how is the patient/patients doing now?.

Event Description

Title: using a ¿no drain¿ policy in 342 laparoscopic hepatectomies: which factors predict failure? author/s: takeaki ishizawa, noah b.Zuker, claudius conrad, hao-jan lei, oriana ciacio, norihiro kokudo & brice gayet.Citation: hpb 2014, 16, 494¿499; doi:10.1111/hpb.12165.The aim of this retrospective study was to identify factors that predict the failure of a ¿no drain¿ policy in laparoscopic hepatectomy.Between 1995 and 2010, 342 patients (male=204, female=138; mean age=61 years, age range=18-88 years) underwent laparoscopic hepatic resection.During the procedure, the liver parenchyma was then dissected using bipolar forceps and ultrasonic shears, usually a sonosurg or harmonic scalpel (ethicon).Reported complications included symptomatic fluid collection (n=?); bile leak (n=?); bleeding (n=?); liver insufficiency (n=?); sepsis (n=?); and stenosis of the bile duct (n=?).In conclusion, prophylactic drainage during liver resection should be considered not only in the presence of uncontrollable bile leak or concern for postoperative bleeding risk, but also in patients who have undergone neoadjuvant chemotherapy and those in whom intraoperative blood loss is >400 ml.Otherwise, a ¿no drain¿ policy is safe and would enhance the advantages of minimally invasive liver surgery.

• Brand Name: HARMONIC ACE 5MM SHEAR
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 9618392
• MDR Text Key: 189481966
• Report Number: 3005075853-2020-00514
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K120729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HARXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other